Our new paper “High-risk without safeguards? The EU AI Act and the push for deregulation of medical AI” is out in BMJ Digital Health & AI. We examine the Digital Omnibus&Health Innovation Package, and what regulatory “simplification” could mean for safeguards for medical AI. doi.org/10.1136/bmjd...

High-risk without safeguards? The EU AI Act and the push for deregulation of medical AI

Artificial intelligence (AI) is increasingly embedded in clinical decision-making, yet recent proposals to simplify the European Union (EU) Artificial Intelligence Act (AI Act) have reopened the quest...

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🎧New podcast: We discuss #AI prominence in the European Commission's #SafeHeartsPlan, opportunities that AI will bring, and the need for robust legal, institutional, and operational frameworks @hvkolfschooten.bsky.social Apple: shorturl.at/Psz66 Spotify: shorturl.at/n2HOh

Artificial intelligence in the EU Safe Hearts Plan with Giulio Stefanini and Hannah van Kolfschooten

Podcast Episode · The Lancet Regional Health Europe in conversation with · August 17 · 23m

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A new EU strategy is placing greater emphasis on the use of artificial intelligence in heart disease management. However, @hvkolfschooten.bsky.social believes this is premature. In an interview, she criticizes the lack of demonstrated benefits for patients and the gaps in the legislation.

AI in cardiology: The path to practical application carries risks

A new EU strategy is placing greater emphasis on artificial intelligence in the management of heart disease. Legal researcher Hannah van Kolfschooten believes this is premature. Among other things, sh...

unibas.ch

Artificial intelligence in the EU Safe Hearts Plan: prediction alone is not enough - The Lancet Regional Health – Europe www.thelancet.com/journals/lan...

Artificial intelligence in the EU Safe Hearts Plan: prediction alone is not enough

The European Commission's Safe Hearts Plan positions AI as a key tool for enhancing the prevention, diagnosis, and care of cardiovascular disease. Although AI presents significant opportunities, the S...

thelancet.com

www.icthealth.org/news/us-medi...

‘US medical AI tools can't simply be transplanted to Europe’ | ICT&health

How to govern health AI without blocking innovation? Hannah van Kolfschooten, researcher at the Centre for Life Sciences Law at the University of Basel, explains why innovation and regulation can go h...

icthealth.org

New paper in Frontiers in Public Health! We argue that AI chatbots are giving rise to shadow health systems: privately governed AI infrastructures that increasingly shape how people make health decisions and seek care, without being regulated as healthcare. doi.org/10.3389/fpub...

Frontiers | Emerging shadow health systems: regulating health-focused generative AI chatbots from a European perspective

ChatGPT Health and other health-focused generative AI chatbots increasingly function as alternative first points of contact that may mediate—and in some case...

doi.org

New open-access: "Prohibited AI Practices in Healthcare under the European Artificial Intelligence Act" by @hvkolfschooten.bsky.social. "Understanding how these categorical prohibitions and their exceptions interact is crucial for sectors like healthcare..." #AIAct www.cambridge.org/core/journal...

petrieflom.law.harvard.edu/2025/08/20/a...

Period tracking apps raise considerable risks & challenges to rights, including data privacy. In countries where reproductive rights are threatened this data can have serious consequences. @hvkolfschooten.bsky.social & @aliceebeck.bsky.social explain more: haiweb.org/period-track...

In a @bmj.com Response, @nicolegross.bsky.social, @aliceebeck.bsky.social &I argue that important gaps remain in the EU AI Act when it comes to the protection of patients' rights. Such regulatory pitfalls risk undermining public trust, safety, and equity ➡️ Read lnkd.in/eedZMKZY @hai-org.bsky.social

Out now in EYHR: 𝐀 𝐇𝐮𝐦𝐚𝐧 𝐑𝐢𝐠𝐡𝐭𝐬-𝐁𝐚𝐬𝐞𝐝 𝐀𝐩𝐩𝐫𝐨𝐚𝐜𝐡 𝐭𝐨 𝐀𝐫𝐭𝐢𝐟𝐢𝐜𝐢𝐚𝐥 𝐈𝐧𝐭𝐞𝐥𝐥𝐢𝐠𝐞𝐧𝐜𝐞 𝐢𝐧 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞: 𝐀 𝐏𝐫𝐨𝐩𝐨𝐬𝐚𝐥 𝐟𝐨𝐫 𝐚 𝐏𝐚𝐭𝐢𝐞𝐧𝐭𝐬’ 𝐑𝐢𝐠𝐡𝐭𝐬 𝐈𝐦𝐩𝐚𝐜𝐭 𝐀𝐬𝐬𝐞𝐬𝐬𝐦𝐞𝐧𝐭 𝐓𝐨𝐨𝐥. How can doctors & informal carers make informed decisions about AI tools in a way that respects patients’ rights? papers.ssrn.com/sol3/papers....

Before using AI tools for mental health, ensure you understand their privacy policies. We heard privacy concerns raised when we talked to people on the streets of Amsterdam. What steps can we take to ensure our private information stays private? 🎬 Watch the full video: lnkd.in/eKqn3dNU

Vandaag in @volkskrant.nl: een interview over mijn proefschrift. “Juist patiënten die minder gezond zijn, of niet goed met een chatbot overweg kunnen, komen op grotere gezondheidsachterstand. Omdat zij niet de doelgroep van zo’n AI-systeem zijn.” Lees meer: www.volkskrant.nl/wetenschap/d...

In #SwissMedicalWeekly, I raise concerns about the growing reliance on genAI systems, such as ChatGPT, in medicine. Unlike purpose-built healthcare chatbots, these tools are not specifically designed for healthcare.They lack the safeguards of certified medical chatbots. 📖 smw.ch/index.php/sm...

Congratulations to Dr. @hvkolfschooten.bsky.social for successfully defending her PhD on ‘Patients’ Rights Protection and AI in Healthcare in the EU’ at UVA under the guidance of Johan Legemaate, @deruijter.bsky.social, and Kristina Irion. bit.ly/3F5Qad6

Patient Rights in the Age of AI: Hannah van Kolfschooten Defends Her PhD at the UvA - LHL

On March 6, 2025, Hannah van Kolfschooten from Law for Health and Life defended her dissertation, "Patients’ Rights Protection and Artificial Intelligence in Healthcare in the European Union."

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What an incredible milestone for our colleague, @hvkolfschooten.bsky.social, who earned her well-deserved PhD yesterday! Hannah’s research delves into how patient rights can be safeguarded amid the rapid advancements of AI technologies in healthcare. Congratulations, Dr. Van Kolfschooten!

I spoke with the @uvalawschool.bsky.social about my dissertation "Patients' Rights Protection and Artificial Intelligence in the European Union". We talked about ambulance software, prediction of intellectual development in babies, hypes, risks, and rights. Read more 👉 www.uva.nl/en/shared-co...

Is AI in healthcare outpacing legal protections? In Digital Society, @hvkolfschooten.bsky.social from Law for Health and Life proposes an EU Charter of Digital Patients’ Rights—adapting privacy & consent and introducing new safeguards for AI-driven care. 🔗 Read more: bit.ly/4gUBb2Z

Towards an EU Charter of Digital Patients’ Rights in the Age of Artificial Intelligence - LHL

Hannah van Kolfschooten recently published an article in Digital Society titled “Towards an EU Charter of Digital Patients’ Rights in the Age of Artificial Intelligence”.

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theconversation.com/healthcare-i...

Healthcare in Africa on brink of crisis as US exits WHO and USAid freezes funds: health scholar explains why

US withdrawal from the WHO and of all foreign aid will have dire consequences for Africa. It’s time the continent took responsibility for its own people.

theconversation.com

Op 6 maart promoveert @hvkolfschooten.bsky.social op het proefschrift: 'Patients’ rights protection and Artificial Intelligence in healthcare in the EU'. Promotoren zijn prof. dr. J. Legemaate en prof. @deruijter.bsky.social. https://bit.ly/4aNarA2 #GezondheidsRecht #EU #PatientenRechten #AI

Bescherming van patiëntenrechten en artificiële intelligentie in de gezondheidszorg in de Europese Unie

Hannah van Kolfschooten promoveert op het proefschrift: 'Patients’ rights protection and Artificial Intelligence in healthcare in the European Union'. Promotoren zijn prof. dr. J. Legemaate en prof. dr. mr. A. de Ruijter. Copromotor is dr. K. Irion.

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Out today: the sixth and final paper of my PhD dissertation on patients' rights protection & AI. In this paper in #DigitalSociety🔓 I propose an 𝑬𝑼 𝑪𝒉𝒂𝒓𝒕𝒆𝒓 𝒇𝒐𝒓 𝑫𝒊𝒈𝒊𝒕𝒂𝒍 𝑷𝒂𝒕𝒊𝒆𝒏𝒕𝒔’ 𝑹𝒊𝒈𝒉𝒕𝒔 to address the specific challenges presented by AI technologies in this sector. Read more 👉 doi.org/10.1007/s442...

Counting down the days for my PhD defence @ University of Amsterdam! 🌟@uvalawschool.bsky.social

Although the #WEF25 claims to be a place for tackling issues like climate change, poverty and inequality, participants continue to drive environmental degradation and climate breakdown both with their #privatejets lifestyles. This has to change. act.gp/taxthesuperrich

Interesting panel (or should I say MANel - where are the women?) about improving efficiency in healthcare with AI at #AIHouseDavos. The panellists named regulation as the biggest constrain for AI implementation. I would like to argue the opposite. #WEF2025

#AIRA is a three-year project with the aims of mapping the uses of artificial intelligence that affect the lives of autistic people, and building up the capacity of autistic people to advocate for themselves. Join today's webinar! ⭐ eucap.eu/aira/

#AI in #mentalhealthcare offers interesting opportunities. Yet, AI also introduces a set of new risks that extend beyond individual patients to broader societal concerns. Read our policy brief with (legal) recommendations here 👉: lnkd.in/eFzWXK_Q 🤖 @hai-org.bsky.social

Curious about the implications of the EU AI Act for healthcare? In #HealthPolicy we give an overview of the new legal obligations for relevant stakeholders (doctors, hospitals, developers…) 🌟 doi.org/10.1016/j.he...

Bringing this over: our paper on health, intersectionality and climate litigation in the @HarvHumRtsJ! 🍀 Wonderful collaboration with @hvkolfschooten.bsky.social and @amintaossom.bsky.social on this important topic. journals.law.harvard.edu/hrj/current/

Interesting event at the Health Ethics & Policy Lab at @ethzurich.bsky.social. Visualizing digital regulation in an interactive tool for health policymakers is exactly what we need right now. Let’s focus on better regulation for health AI - not less. 💫